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Wesana Health Commits Funding of $1.5 Million To Support MAPS’ Research Pipeline

Wesana Health Commits Funding of $1.5 Million To Support MAPS’ Research Pipeline

MAPS to Investigate Viability of Research Pathway for MDMA-Assisted Therapy to Treat Traumatic Brain Injury

Effort Positions MAPS, Sponsor of the Only Completed Phase 3 Trial for Psychedelic-Assisted Therapy, to Serve New Unique Role Within 

CHICAGO, Sept. 14, 2021 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc.  (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), an emerging data-driven life sciences company focused on developing innovative approaches for better understanding, protecting and improving neurological health and performance, including through the advancement of psychedelic medicines, announced its commitment to fund an initial US $1.5 million to assess the viability of Multidisciplinary Association for Psychedelic Studies (MAPS) MDMA-assisted therapy to treat traumatic brain injury (TBI).

Under the terms of the recently signed memorandum of understanding, Wesana’s financial commitment will enable MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), to activate a team to evaluate the scope of unmet need for TBI treatment and help to define terms of a desired joint venture between MAPS and Wesana. Use of funds will include, in part, legal support in drafting and finalizing a partnership agreement, business development and executive staff costs in evaluating viability of the treatment, and other research-related expenses including establishing ethical guidelines governing the desired agreement.

MAPS’ research has primarily focused on MDMA-assisted therapy for PTSD, with the first of two Phase 3 trials demonstrating a clinically significant reduction in PTSD symptoms for 88% of participants. Similar to PTSD, TBI can have profound, diverse, and life-long impacts on a person’s physical and mental health. Lingering visible and invisible challenges interfere with work, education, and relationships, with disproportionate impacts for people of color. While leading front-line treatments are considered effective for some individuals or types of injury, more than 6.2 million Americans are estimated to have chronic TBI-related disabilities and millions more live with milder, yet disruptive, symptoms. Nearly 414,000 Iraq and Afghanistan Veterans had a TBI and for many, long-term negative health outcomes are poorly understood.

“Wesana is a serious, thoughtful and ethical company engaged in the development of psychedelic-assisted therapy. What Daniel and his team are doing is in line with MAPS’ ethics, mission, values and scientific rigor, and we believe together, MAPS and Wesana can bring much needed help to the massively underserved TBI population. Data collected from MAPS-sponsored Phase 3 clinical trials suggests that MDMA-assisted therapy appears promising in the treatment of TBI. Consistent with our mission, we seek to investigate treatments for affected patients who can be helped by MDMA – this is an important step in that direction” said MAPS Executive Director Rick Doblin, Ph.D.

Daniel Carcillo, CEO of Wesana Health added “The work MAPS has done for more than 35 years with regulators and clinical researchers to navigate the rigorous and necessary FDA approval process for MDMA therapeutic use has positioned psychedelic-assisted therapy on the precipice of national – and global – acceptance. The millions of people afflicted with PTSD may soon have access to MDMA therapy, and we believe the millions suffering from TBI may experience similar relief in the future.”

This first-of-its-kind research collaboration between MAPS and Wesana will accelerate MAPS PBC’s research timelines and provide additional support for further research, advocacy, education, and equitable access to MDMA-assisted therapy treatments. Under the terms of the relationship, Wesana is expected to:

  • Gain expertise and information to design psychedelic-assisted therapy programs for TBI and improve the Wesana timeline and path to market for its treatments
  • Explore obtaining an exclusive commercial license to use MDMA for the treatment of TBI
  • Evaluate the viability of revenue share agreements between the organizations
  • Adapt MAPS’ equitable access research projects to develop a meaningful patient access program
  • Fund associated research, administered by MAPS PBC, with additional capital

Carcillo continued, “Success in forming a research collaboration with MAPS is expected to shrink Wesana Health’s time to market for MDMA therapy for TBI to a handful of years. With millions of people around the world experiencing injuries impacting their brain health, our hope is that through this partnership we will soon deliver meaningful help to the victims, families, friends and communities affected by TBI.”

Note
The safety and efficacy of MDMA-assisted therapy is currently under investigation. It has not yet been approved by the FDA, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future FDA approval or availability of MDMA-assisted therapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from our projections.

The formation of a long-term partnership between Wesana and MAPs remains subject to, among other things, negotiation and execution of definitive documentation and satisfaction of the conditions precedent negotiated therein. There is no assurance that any such definitive documentation will be settled and entered into by the parties nor that any such conditions precedent will be met.

About Wesana
Wesana is an emerging life sciences company championing the development and delivery of psychedelic and naturally-sourced therapies to treat traumatic brain injury (TBI) and other neurological conditions. Through extensive clinical research and academic partnerships, Wesana is developing evidence-based formulations and protocols that empower patients to overcome neurological, psychological and mental health ailments caused by trauma.

Learn more at www.wesanahealth.com

Forward-Looking Information and Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company and MAPs, including, but not limited to: information concerning the completion and timing of completion of the initial US$1.5 million funding to MAPs, information concerning the completion and timing of entering into a partnership with MAPs, expectations regarding whether the contemplated partnership will be consummated, including whether conditions to the consummation of the partnership will be satisfied, expectations for the effects of the contemplated partnership on the business of the Company, expectations regarding the markets to be entered into by the Company as a result of the contemplated partnership, the ability of the Company to successfully achieve its business objectives as a result of entering into the contemplated partnership, expectations regarding the method by which future revenue is generated, expectations regarding the safety and efficacy of MDMA-assisted therapy, including therapies that are being developed by MAPs, and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information.

Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made including among other things assumptions about the ability of the Company to successfully negotiate and enter into definitive documentation in respect of the contemplated partnership with MAPs and satisfy any related conditions precedent; the ability of the Company to raise sufficient capital to advance the business of the Company, including to be able to fund such partnership with MAPs; development costs remaining consistent with budgets; favorable equity and debt capital markets; favorable operating conditions; obtaining and maintaining all required licenses and permits; receipt of governmental approvals and permits; political and regulatory stability; the level of demand for the Company’s proposed products and services; the ability of the Company to be successful in its research and development initiatives; and the availability of third party service providers and other inputs for the Company’s operations. While the Company considers these assumptions to be reasonable, the assumptions are inherently subject to significant business, social, economic, political, regulatory, competitive and other risks and uncertainties, contingencies and other factors that could cause actual performance, achievements, actions, events, results or conditions to be materially different from those projected in the forward-looking information. Many assumptions are based on factors and events that are not within the control of the Company and there is no assurance they will prove to be correct.

Furthermore, such forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual plans, intentions, activities, results, financial position, performance or achievements of the Company to be materially different from any future plans, intentions, activities, results, financial position, performance or achievements expressed or implied by such forward-looking information. Such factors include, among others: the inability of the Company to successfully negotiate and enter into definitive documentation in respect of the contemplated partnership with MAPs and satisfy any related conditions precedent; the inability of the Company to raise sufficient capital to advance the business of the Company, including to be able to fund such partnership with MAPs; and such other risks factors discussed in the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and in the Company’s other public filings available on SEDAR. Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such forward-looking information will prove to be accurate as actual results and future events could differ materially from those anticipated in such information. Accordingly, readers should not place undue reliance on forward-looking information. Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.

For more information, please contact:

Media Contact:
Nick Opich / Annie Graf
KCSA Strategic Communications
Email: Wesana@kcsa.com
Phone: 212-896-1206 / 786-390-2644

On behalf of the Board of Directors:
Daniel Carcillo, Chief Executive Officer
Phone: (773) 236-7972

Source: Wesana Health

Released September 14, 2021

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Perception Neuroscience initiates Phase 2a study of PCN-101 (R-ketamine) for treatment resistant depression

Perception Neuroscience initiates Phase 2a study of PCN-101 (R-ketamine) for treatment resistant depression

NEW YORK and BERLIN, Sept. 14, 2021 (GLOBE NEWSWIRE) — Perception Neuroscience (Perception), an atai Life Sciences (atai) biopharmaceutical company focused on developing innovative therapies in neuropsychiatric diseases, today announced the initiation of a Phase 2a clinical study to evaluate the safety and efficacy of PCN-101 (R-ketamine). R-ketamine is a stereoisomer of ketamine being developed for therapeutic treatment of psychiatric disorders such as Treatment Resistant Depression (TRD). The Phase 2a clinical trial has received the necessary regulatory and ethics approvals to initiate the study.

The Phase 2a trial is a double blind, placebo-controlled study in patients with TRD. Each of the 3 parallel arms will enroll 31 patients at multiple locations. Patients will receive either placebo, a 30 mg dose, or a 60 mg dose of R-ketamine intravenously.

Patients will be assessed for depressive symptomology over the subsequent 14 days using the Montgomery-Asberg Depression Rate Scale, or MADRS. Topline data from the study is expected to be reported at the end of 2022.

“We’re excited to take the next key step with this clinical trial to show the potential of PCN-101 for people living with TRD,” said Terence Kelly, PhD, CEO of Perception Neuroscience. “TRD impacts nearly 100 million people around the world, making up a third of patients living with depression; currently they are either undertreated or unresponsive to existing treatment options. We believe PCN-101 holds promise in helping such treatment-resistant patients, as a potential rapidly-acting antidepressant which can be administered at home.”

“We believe insight into the molecular properties of the single isomer, R-ketamine, has the potential to offer a highly differentiated profile from current treatment options,” added Florian Brand, CEO & Co-founder of atai Life Sciences. “Initiating this Phase 2 clinical study is a major step for our teams at Perception and atai and is a great achievement. We believe this work has the potential to deliver a novel option with diversified delivery capabilities that could decrease overall healthcare utilization, which may help us move toward our greater mission to improve care for patients who suffer from TRD.”

About PCN-101
Perception Neuroscience is developing PCN-101 (R-ketamine) for the treatment of Treatment Resistant Depression. PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid acting antidepressant (RAAD) activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Nonclinical depression model studies in rodents suggest that R-ketamine could possess more durable and potent effects than S-ketamine despite a lower affinity to the NDMA receptor and potentially a more favorable safety and tolerability profile.

About Perception Neuroscience, Inc
Perception Neuroscience is a New York City-based biopharmaceutical company committed to developing therapies for neuropsychiatric diseases. Perception’s mission is to provide substantially more effective treatment solutions to serious psychiatric disorders. The company is a majority-owned subsidiary of atai Life Sciences.

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific, and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including without limitation statements regarding the initiation of the Phase 2a trial by Perception and future activities thereunder, the potential of PCN-101, and similar statements of a future or forward-looking nature. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.

Investor Contact:
Greg Weaver
Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

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Mindset Pharma Further Validates Lead Candidate, MSP-1014, as a Next Generation Psilocybin Analog through Drug Discrimination Assay

Mindset Pharma Further Validates Lead Candidate, MSP-1014, as a Next Generation Psilocybin Analog through Drug Discrimination Assay

TORONTO, Sept. 14, 2021 (GLOBE NEWSWIRE) — Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (“Mindset” or the “Company“), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today announced that its lead candidate, MSP-1014, was comparable to psilocybin assessed using a drug discrimination assay. The results suggest that MSP-1014 induces a similar perceptual state to psilocybin, further confirming the viability of MSP-1014 as a therapeutic analog of first-generation psilocybin as the Company advances MSP-1014 into the clinic.

“In the drug discrimination assay, MSP-1014 demonstrated a dose dependent and full generalization to a psilocybin discriminative cue in rats,” stated Joseph Araujo, Chief Scientific Officer of Mindset. “Furthermore, we identified an effective dosage of 0.6 mg/kg for subcutaneous administration of MSP-1014 with no detrimental effect on the response rate up to doses of 2 mg/kg. MSP-1014 also showed a dose dependent generalization to a psilocybin cue following the oral route of administration. These results further validate MSP-1014 as an effective second-generation psilocybin-like drug candidate.”

“We continue to perform studies across various preclinical models with MSP-1014 and our library of next generation psychedelic compounds. Our goal is to show the differentiation of our novel drug candidates and build a catalog of translational data as we prepare for human clinical trials,” said James Lanthier, CEO of Mindset.

To watch a video of Mindset’s CEO discussing the announcement in greater detail, please visit: https://youtu.be/tYa3sFjGblY.

For more information, please contact:

Investor Contact:
Allison Soss/Tim Regan
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 212-896-1267/ 347-487-6788

Company Contact:
James Lanthier, CEO
Email: jlanthier@mindsetpharma.com

Jason Atkinson, VP, Corporate Development
Email: jatkinson@mindsetpharma.com
Phone: 416-479-4094

About Mindset Pharma Inc.
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds.

For further information on Mindset, please visit our website at www.mindsetpharma.com.

Forward-Looking Information

This news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “would”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company’s business are contained under the heading “Risk Factors” in the Company’s annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

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Perception Neuroscience initiates Phase 2a study of PCN-101 (R-ketamine) for treatment resistant depression

NEW YORK and BERLIN, Sept. 14, 2021 (GLOBE NEWSWIRE) — Perception Neuroscience (Perception), an atai Life Sciences (atai) biopharmaceutical company focused on developing innovative therapies in neuropsychiatric diseases, today announced the initiation of a Phase 2a clinical study to evaluate the safety and efficacy of PCN-101 (R-ketamine). R-ketamine is a stereoisomer of ketamine being developed for therapeutic treatment of psychiatric disorders such as Treatment Resistant Depression (TRD). The Phase 2a clinical trial has received the necessary regulatory and ethics approvals to initiate the study.

The Phase 2a trial is a double blind, placebo-controlled study in patients with TRD. Each of the 3 parallel arms will enroll 31 patients at multiple locations. Patients will receive either placebo, a 30 mg dose, or a 60 mg dose of R-ketamine intravenously.

Patients will be assessed for depressive symptomology over the subsequent 14 days using the Montgomery-Asberg Depression Rate Scale, or MADRS. Topline data from the study is expected to be reported at the end of 2022.

“We’re excited to take the next key step with this clinical trial to show the potential of PCN-101 for people living with TRD,” said Terence Kelly, PhD, CEO of Perception Neuroscience. “TRD impacts nearly 100 million people around the world, making up a third of patients living with depression; currently they are either undertreated or unresponsive to existing treatment options. We believe PCN-101 holds promise in helping such treatment-resistant patients, as a potential rapidly-acting antidepressant which can be administered at home.”

“We believe insight into the molecular properties of the single isomer, R-ketamine, has the potential to offer a highly differentiated profile from current treatment options,” added Florian Brand, CEO & Co-founder of atai Life Sciences. “Initiating this Phase 2 clinical study is a major step for our teams at Perception and atai and is a great achievement. We believe this work has the potential to deliver a novel option with diversified delivery capabilities that could decrease overall healthcare utilization, which may help us move toward our greater mission to improve care for patients who suffer from TRD.”

About PCN-101
Perception Neuroscience is developing PCN-101 (R-ketamine) for the treatment of Treatment Resistant Depression. PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid acting antidepressant (RAAD) activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Nonclinical depression model studies in rodents suggest that R-ketamine could possess more durable and potent effects than S-ketamine despite a lower affinity to the NDMA receptor and potentially a more favorable safety and tolerability profile.

About Perception Neuroscience, Inc
Perception Neuroscience is a New York City-based biopharmaceutical company committed to developing therapies for neuropsychiatric diseases. Perception’s mission is to provide substantially more effective treatment solutions to serious psychiatric disorders. The company is a majority-owned subsidiary of atai Life Sciences.

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific, and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including without limitation statements regarding the initiation of the Phase 2a trial by Perception and future activities thereunder, the potential of PCN-101, and similar statements of a future or forward-looking nature. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.

Investor Contact:
Greg Weaver
Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

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Supporting the next generation of psychedelic journalists

Tim Ferriss Gift Creates Journalism Fellowships at Berkeley’s new Center for Science of Psychedelics

“As the field of psychedelics explodes, we’re going to need sophisticated journalism to provide the public with reliable information and the field with accountability.”

That’s where Tim Ferriss steps in.

His non-profit organization, the Saisei Foundation, just donated $800,000 over three years to UC Berkeley’s Center for the Science of Psychedelics (BCSP) to establish the Ferriss – UC Berkeley Psychedelic Journalism Fellowship.

The fellowship, which will be overseen by BCSP co-founder Michael Pollan, will support young journalists reporting on the psychedelics industry for mainstream news outlets. Journalists can apply to receive grants of up to $15,000 to investigate the science, policy, business and culture of psychedelics.

PDF of article

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Blackhawk Growth’s MindBio Therapeutics Opens World Class Facility for the Pharmaceutical Industry

Blackhawk Growth’s MindBio Therapeutics Opens World Class Facility for the Pharmaceutical Industry

Vancouver, British Columbia – TheNewswire – September 13, 2021 – Blackhawk Growth Corp. (CNSX:BLR.CN) (OTC:BLRZF) (Frankfurt:0JJ) (the “Company” or “Blackhawk”) is pleased to provide an update on MindBio Therapeutics Pty Ltd. (“MindBio Therapeutics”), a clinical stage drug development company conducting research into microdosing and medicinal use of psychedelic medicine.

MindBio Therapeutics is excited to announce that it will open a world class facility providing research and drug development as a service to the pharmaceutical industry to potential clients in the United States and Canada. Companies in the psychedelic and pharmaceutical industry can now contract with MindBio Therapeutics for research and drug development on any psychedelic compound. Large pharmaceutical companies are increasingly looking to create synthetics compounds of psychedelics and MindBio Therapeutics has the ideal platform and access to infrastructure to help accelerate this activity.

With its exclusive agreement with the University of Auckland, MindBio has access to expansive infrastructure to bring psychedelic medicines to market. This includes research and drug development, ethical clinical expertise, clinical trial design, regulatory approvals, and formulation expertise. They have a multidisciplinary team with an interphase between medicines, psychiatry, and technology teams that can collaborate on building world class solutions for a wide range of mental health conditions. These facilities have neuroimaging technologies including EEG and MRI technology and have also opened a new clinic research centre including 30 clinical research rooms that is supported with world class pathology labs.

MindBio’s solution is cost effective, providing fast access to research and drug development infrastructure and can service clients globally. MindBio is already in discussions with several potential customers in the United States and sees a great opportunity for potentially generating ongoing revenue and licensing income from this new service offering.

About Blackhawk Growth

Blackhawk is an investment holding looking to create substantial value for its shareholders through the acquisition and development of high growth companies. It has focused its investments in the health, cannabis and cannabidiol industries in both Canada and the United States. Its portfolio of companies includes Sac Pharma, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods, and MindBio Therapeutics. Blackhawk continues to bring its investments to cash flow and is growing at an exceeding pace.

The Company diligently posts updates through videos from the official company YouTube channel https://www.youtube.com/channel/UCs4f2tt3yAvOGhNLjgNOy-A

Please join the conversation on our Blackhawk group supporter’s telegram group at https://t.me/Blackhawkgrowthcorp and visit us online at https://www.blackhawkgrowth.com.

For further information please contact:

Frederick Pels, Chief Executive Officer

(403)-991-7737

fred@blackhawkgrowth.com

Cautionary Note Regarding Forward-Looking Statement

All statements in this press release, other than statements of historical fact, are “forward-looking information” with respect to the Company within the meaning of applicable securities laws, including with respect to transaction and future operations of MindBio Therapeutics Pty Ltd. The Company provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Company’s public filings under the Company’s SEDAR profile at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.

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Lobe Sciences Provides Corporate Update to Investors and Stakeholders

Lobe Sciences Provides Corporate Update to Investors and Stakeholders

Vancouver, British Columbia–(Newsfile Corp. – September 13, 2021) – Lobe Sciences Ltd. (CSE: LOBE) (OTC Pink: GTSIF) (“Lobe” or the “Company“) is pleased to provide the following corporate update by CEO Philip Young, addressed to shareholders, investors and other stakeholders of the Company:

Dear Fellow Shareholders and Psychedelic Medicine Enthusiasts,

We are pleased to say that 2021 has been a busy and transformative year for the Company. During 2021, we have made significant progress on several fronts, and completed our transition to an integrated pharmaceutical development company. We have built the foundation of a drug development company and we are now following a path for the development of therapeutics for which we intend to seek FDA approval in the United States, and similar approvals internationally. Millions of people are experiencing the devastating, often long-term effects of mTBI (mild traumatic brain injury) and PTSD (post-traumatic stress disorder), with few, if any, effective treatments available. Our goal is to change that fact. We believe that psychedelic based therapeutics will bring a new era of treatment for many illnesses where current therapies are insufficient or unavailable. As such, we believe the Company is poised to lead the way in developing treatments for mTBI and PTSD, while altering the perception of psychedelic medicine as a treatment modality. Our entire team is dedicated to making a significant impact in this rapidly growing industry as we differentiate ourselves from other psychedelic medicine companies by executing our strategic plans and vision. The following is a brief review of the achievements we have made, laying the foundation for continued progress and milestones, which we believe will position the Company for long-term growth and success.

2021 Business Developments – the building blocks for our future

Our 2021 accomplishments spanned every aspect of our business as we executed our multi-prong strategy and vision for future developments. These accomplishments included: streamlining operations, enhancing our balance sheet, strengthening our intellectual property portfolio, further developing our medical devices, increasing our scientific breadth and reach by forming a world class scientific advisory board and entering into relationships with key organizations that promote mental health and wellness. Key accomplishments include:

Clinical and Scientific Developments and Operations:

Our pre-clinical study involving psilocybin and NAC (N-Acetylcysteine) led by Principal Investigator, Dr. Michael Hoffer of the University of Miami is progressing and in the process of analyzing the data. The Company continued to strengthen its overall product, device and intellectual property (“IP“) portfolio through acquisitions and our development efforts. Other key highlights include:

  • On February 18, 2021 we announced the successful completion and testing of the proof of concept prototype of its proprietary nasal mist device;
  • On April 27, 2021 we announced the Company entered into a joint venture agreement with Virtual Psychedelics Incorporated to design, develop and commercialize the Krysalis Pod, a state-of-the-art media device that will deliver immersive virtual experiences without a headset. (the “JV”);
  • On April 29, 2021 we announced the filing of a PCT application entitled “Methods, Compositions and Devices for Treating Mild Traumatic Brain Injury”;
  • On May 4, 2021 we announced the acquisition of the Vitamind line of functional mushroom wellness products; and
  • On May 19, 2021 we announced entering into a production and supply agreement with HAVN Life Sciences Inc.

As announced on March 8, 2021, the Company completed the divestiture of the Washington State cannabis asset to Ionic Brands Corp. (“Ionic“), strengthening our balance sheet with a cash payment to the Company of $1,750,000, and receipt of 100,406,701 Series E shares of Ionic and 4,000,000 Ionic warrants.

Executive Team, Advisors and Industry Relationships:

In 2021, in addition to myself as CEO, we added Michael Petter, an accomplished businessman to our board of directors. We also assembled an accomplished Scientific Advisory Board (“SAB”), led by our CSO, Maghsoud Dariani, including Dr. Mark Geyer, Dr. Charles Grob, Dr. Benjamin Kelmendi, Dr. Michael Hoffer and Dr. Skip Rizzo, all regarded as leaders and innovators in their respective psychedelic and medical communities. We also leveraged our advisor network and partnered with the NFL Alumni Association and the World Boxing Association to investigate and develop plans for monitoring, mitigating and managing the consequences of mTBI and PTSD.

Looking Ahead: on-going corporate initiatives

The Company intends to leverage its 2021 accomplishments achieved to-date. Key milestones we anticipate working towards include the following items. The Company plans on completing these items by the end of calendar 2022, barring any unforeseen delays.

Clinical and Scientific Development and Regulatory

  • Announce the results of the University of Miami Pre Clinical Study of the treatment of mTBI and PTSD
  • Submit Pre Investigational New Drug (“IND“) meeting request to FDA
  • Announce contract research organization (“CRO“) partner, finalize study protocol, select sites for first-in-man study with our combination therapeutics
  • Finalize agreement with a cGMP manufacturing partner for clinical trial and commercial supplies of psilocybin and NAC (N-Acetylcysteine)
  • Initiate the first human study with Lobe’s patent pending combination therapeutics of psilocybin and NAC (N-Acetylcysteine)
  • Update on cGMP psilocybin production timing and availability
  • File IND with FDA
  • Update clinical trial enrolment progress
  • Update IND plans based on feedback from FDA
  • Finalize specifications for and design plan for nasal mist delivery device

Collaborations and Partnerships

  • Update on Krysalis Pod design team and progress
  • Launch the first products in the Vitamind product portfolio, subject to regulatory approval
  • Update on Krysalis Pod design and tech stack development
  • Expand Vitamind product offerings and launch in USA, subject to regulatory approval

Investment Conference Schedule:

The Company will be sharing its vision and plans with investors as we attend several leading investment conferences and trade conventions including:

  • HC Wainwright 23rd Global Investment Conference, September 13-15, 2021
  • Maxim Group, Advances in Mental Health – Psychedelics and Non-Psychedelics Conference, September 22, 2021
  • Benzinga Healthcare Small Cap Conference, September 29, 2021
  • MoneyShow Virtual Expo, October 5-7, 2021
  • BioFuture 2021, October 5-7, 2021
  • LD Micro Main Event, October 12-14, 2021
  • Q4 Investor Summit Virtual Conference, November 16-17, 2021
  • JP Morgan Healthcare Conference, January 10-13, 2022

In summary, we believe the balance of 2021 and 2022 will bring exciting developments as we build on the foundation of our accomplishments. We are committed to creating effective therapies and treatments to better the lives of millions of people. We believe we have built a solid foundation and strategy that incorporates strong partnerships with recognized industry leaders, a world-class Scientific Advisory Board, a growing intellectual property portfolio, along with multiple products and devices under development.

Thank you for your continued commitment and support as we continue to execute our strategy to position the Company for long-term growth and success.

Philip Young
CEO and Director

* * *

About Lobe Sciences Ltd.

Lobe Sciences is a life sciences company focused on psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.

For further information please contact:

Lobe Sciences Ltd.
Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623

THE CSE HAS NOT REVIEWED AND DOES NOT ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.

Disclaimer for Forward-Looking Statements

This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact included in this release, including statements made by our Chief Executive Officer and regarding the future plans and objectives of the Company; progression with nasal mist device engineering and commercialization; the pursuit of M&A initiatives, and the expected benefits to be derived from previous M&A initiatives; the development of effective delivery methods and commercialization potential of the nasal mist device, research and development using NAC and psilocybin and growth of the business; the Company’s expected attendance at various industry conferences; the timing of and results from the University of Miami pre-clinical study; expected timing to submit a pre IND meeting request to the FDA (and statements regarding FDA approvals generally); expected announcement and timing of a CRO partner, finalizing study protocol, and statements regarding a first-in-man study with our combination therapeutics; statements regarding expected development of the Krysalis Pod; anticipated timing and announcement of initiation of the first human study with Lobe’s patent pending combination therapeutics of psilocybin and NAC (N-Acetylcysteine); expected timing and occurrence of the launch of products in the Vitamind product portfolio, expansion of the Vitamind product line and receipt of regulatory approvals required for product launches; expected statements and timing regarding cGMP psilocybin production and availability; and the expected timing for the launch of new products and revenue-generating activities and expected completion of milestones by the end of calendar 2022, are all forward looking statements that involve risks and uncertainties. Forward-looking statements, by their very nature, require management to make assumptions and are subject to inherent risks and uncertainties, and while management of the Company believes the forward-looking statements contained herein have a reasonable basis, the possibility exists that our predictions, forecasts, projections, expectations or conclusions will not prove to be accurate. Material assumptions that underlie the forward-looking statements included in this news release include, without limitation, assumptions regarding: the outcomes of scientific studies showing the efficacy of psychedelic therapies on mTBI and PTSD, increasing acceptance in the medical community and among consumers for psychedelic therapies as an effective treatment modality; the Company having access to sufficient capital needed to support its various milestone objectives, expected synergies from M&A transactions and the timing of various milestone objectives, regulatory approvals and our ability to capitalize on business opportunities and develop revenue-generating activities; and the impact of COVID-19 on our business plans. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. As a result of the inherent uncertainty of forward-looking statements, there can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements, whether as a result of known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. Important risks and uncertainties that could cause actual results to differ materially from the Company’s expectations include without limitation risks relating to: that we may not have the capital needed or will not be able to raise sufficient capital to support our business activities or achieve our anticipated milestones; delays or stoppages in the Company’s business activities resulting from the COVID-19 pandemic; adverse or unexpected findings in scientific research; adverse changes to the regulatory environment in which we operate; regulatory delays or the failure to obtain required regulatory approvals; failure to capitalize on business opportunities and develop revenue-generating activities; contract counterparty risks; key personnel risk; business integration risks; risks inherent to equity and debt markets and their effects on our share price, and such other risks as may be detailed from time to time in the filings made by the Company pursuant to securities regulations, as well as other risks that may presently be unknown to us or which we consider to be immaterial at the time such forward-looking statements are made. As a result of these risks and uncertainties, the Company cannot guarantee that any forward-looking statement will materialize as expected, and the reader is therefore cautioned not to place undue reliance on any forward-looking statements contained in this news release. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement, are made only as of the date of this news release and the Company does not intend to update any of the forward-looking statements contained in this news release except as expressly required by applicable securities laws.

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PharmaTher Provides Product Pipeline Updates and Anticipated Milestones for Q4-2021 and 2022

PharmaTher Provides Product Pipeline Updates and Anticipated Milestones for Q4-2021 and 2022

  • 10 clinical sites selected to participate in the FDA Phase 2 clinical study evaluating ketamine for the treatment of Parkinson’s Disease
  • Initiated investigational new drug (IND) application to proceed to a Phase 2 clinical study for KETABET™ to treat depression
  • Completed Phase 2 clinical study protocol for ketamine to treat ALS for IND submission to the FDA
  • Near completion of research programs to advance novel microneedle patches for the delivery of psychedelics
  • Selected U.S.-based CDMO to develop and supply proprietary ketamine products for FDA Phase 3 clinical studies and commercialization
  • Positioned ketamine focused product pipeline for potential Phase 3 clinical studies and commercial supply in 2022

TORONTO, September 13, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to provide a product pipeline update and anticipated milestones for Q4-2021 and 2022 including ongoing FDA Phase 2 clinical study programs, microneedle patch delivery programs for psychedelics, and clinical, commercial manufacturing and supply for its proprietary ketamine and microneedle patch products.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “I am very pleased with the progress of our clinical programs for ketamine as a potential treatment for Parkinson’s disease, ALS and depression.  Our research programs for microneedle patch delivery are nearing completion and preparations for FDA Phase 1 and 2 clinical studies are on track.  To support these and future programs, we are securing manufacturing and supply of our proprietary ketamine products and microneedle patches for planned FDA Phase 2 and 3 clinical studies and commercialization in 2022 and beyond.  We remain focused on achieving our milestones in Q4-2021 and building a solid foundation that will allow us to become a leader in the development and commercialization of novel ketamine-based products. In addition, our intradermal delivery of ketamine and psychedelics via our proprietary microneedle patches position us for potential next-generation therapeutic solutions for mental health, neurological and pain disorders.”

FDA Phase 2 Clinical Study Programs     

For the rest of 2021, PharmaTher will focus on advancing three promising developments through FDA Phase 2 clinical studies:

Ketamine for Parkinson’s Disease    

The FDA’s approval to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease triggered clinical program execution.  The Company has completed its clinical trial start-up activities and selection of essential vendors including  project management, central laboratory, clinical supply kits and logistics, data management and biostatistics, and clinical site management and monitoring.  Clinical trial drug product (ketamine) and active placebo (midazolam) have also been obtained.  

More importantly, the Company has selected ten (10) clinical sites in the U.S. to participate in the Phase 2 clinical study.  Patient screening has begun and the Company expects patient enrollment to support the delivery of clinical results in Q4-2021.

For further detail about the study (ClinicalTrials.gov Identifier: NCT04912115), titled “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease,” please visit https://clinicaltrials.gov/ct2/show/NCT04912115?term=PharmaTher&draw=2&rank=1.

If the Phase 2 clinical study is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)2 regulatory pathway in the first half of 2022.   

KETABET™ for Treatment-Resistant Depression    

The Company has finalized the Phase 2 clinical study protocol to evaluate KETABET™ for treatment-resistant depression.  The Company is working with its scientific and clinical advisor, Dr. Maurizio Fava, MD, with the aim to complete the IND and file it with the FDA in early October.  With the overlap of the clinical operations from the Parkinson’s disease study, the Company has already activated start-up activities and identified potential clinical sites to screen and enroll patients for the proposed Phase 2 clinical study in Q4-2021.  The aim is to share initial clinical results by the end of this year.

Assuming the Phase 2 clinical study is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)2 regulatory pathway in the first half of 2022.

KETABET™ is the Company’s patented combination formulation of FDA-approved ketamine and betaine as a potential next-generation treatment for neuropsychiatric disorders.  More than 300 million people suffer from major depressive disorder and of those, 100 million are resistant to available treatments worldwide.   KETABET™ research has shown potential enhancement of the antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine.1  Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.

Ketamine for Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s Disease)       

The Company has been granted orphan drug designation by the FDA for ketamine to treat ALS and along with its clinical advisors, has finalized the Phase 2 clinical study protocol. The IND application for this study is in process and will be filed with the FDA in October 2021 with patient enrollment targeting Q1-2022.

PharmaTher has an exclusive license agreement with the University of Kansas for the intellectual property protecting the potential use of ketamine to treat ALS.  Preclinical research has shown that the administration of ketamine preserves muscle function in advancing ALS and could potentially increase life expectancy when given in the early stages of muscle decline.

Proprietary Microneedle Patch Delivery Programs for Psychedelics    

PharmaTher is working with its research and development partners to advance next-generation microneedle patches for the delivery of psychedelics:

Hydrogel-Forming Microneedle Delivery Technology for Ketamine           

PharmaTher has exclusive worldwide development and commercial rights for the delivery of ketamine, esketamine and KETABET™ using a patented hydrogel-forming microneedle patch.  The Company is working with Professor Ryan Donnelly under a research agreement with The Queen’s University of Belfast to develop the microneedle patch for the delivery of ketamine and KETABET™.  Foundational research is almost complete and final research results will become available in December 2021.   To date, initial proof of concept with ketamine and KETABET™ is very encouraging.  The Company is currently preparing for validation and tech transfer activities to support Phase 1 and Phase 2 clinical studies in 2022.  Development progress will be made available as they arise for the remainder of the year.

The Company’s microneedle patch leverages the successful proof of concept achieved in delivering esketamine, the S(+) enantiomer of ketamine, via the microneedle patch, which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format.2  Details of the research can be found in a published paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery.” 

GelMA Microneedle Delivery Technology for Psychedelics

The Company is working with the Terasaki Institute under a research agreement to finalize the development of a proprietary microneedle delivery technology comprised of a biocompatible and biodegradable gelatin methacryloy (GelMA) composite for use with psychedelics such as psilocybin, DMT, MDMA and LSD.  The GelMA patch delivery technology is the driving force of the Company’s psychedelics microdosing program.  The research program is almost complete and successful proof of concept with psilocybin and LSD has been achieved.  Full research results will be made available in November 2021.  The Company is currently preparing for validation and tech transfer activities to support Phase 1 and Phase 2 clinical studies in 2022.

Clinical and Commercial Manufacturing and Supply Initiatives          

Proprietary Ketamine

PharmaTher is focused on building a specialty ketamine-based product pipeline.  The Company has selected a U.S.-based GMP contract development and manufacturing organization (CDMO) with extensive experience in the development, production and supply of clinical and commercial controlled substance sterile products.  PharmaTher will work with the CDMO to develop the Company’s proprietary ketamine drug product(s) to support future clinical studies and global commercial supply.

It is expected that the proprietary ketamine drug products will be available for FDA Phase 3 clinical studies and commercialization in H2-2022.

Proprietary Microneedle Patch

The Company entered into a co-development agreement with TSRL, Inc. to jointly develop the patented hydrogel-forming microneedle patch delivery technology.  This allows the Companies to control the manufacturing and supply of microneedle patches for their respective clinical and commercial drug programs.

PharmaTher is focused on incorporating psychedelics and TSRL is focused on incorporating antiviral medications in a microneedle patch with the potential to improve the safety (i.e. fewer side effects), efficacy (i.e. bioavailability, optimized dosing regimen including continuous system delivery) and compliance (i.e. storage, distribution and self-administration) of these compounds that currently must be taken orally, inhaled, injected and intravenously.

Recent activities included the tech transfer for scale-up and manufacturing of clinical supplies to a GMP contract research lab and a pre-IND meeting with the FDA that achieved agreement with the agency on proposed 505(b)2 product development plans.

The Company aims to validate non-clinical and clinical production of the microneedle patch by October 2021 and begin non-clinical and clinical manufacturing supply at the end of 2021.  The Company expects to enter into Phase 1 and 2 clinical studies in 2022 to evaluate its microneedle patch in delivering ketamine, KETABET™, psilocybin, DMT, MDMA and LSD.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, including ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently conducting an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing novel microneedle patches for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of May 31, 2021 (“MD&A”), dated September 7, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

References:

  1. J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice, Psychopharmacology (Berl). 233 (2016) 3223–32.
  2. Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.
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Novamind to Serve as Research Site for Karuna Therapeutics Late-Stage Clinical Trial

Novamind to Serve as Research Site for Karuna Therapeutics Late-Stage Clinical Trial

Cedar Clinical Research to Host Phase III Trial for Investigational Therapy for Schizophrenia

TORONTO, ON / September 13, 2021 / Novamind Inc. (CSE: NM | OTCQB: NVMDF | FSE: HN2) (“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine, is pleased to announce that its wholly owned subsidiary, Cedar Clinical Research (“CCR”) has been selected as a research site for a clinical trial sponsored by Karuna Therapeutics, Inc. (“Karuna”), a clinical-stage neuroscience biopharmaceutical company.

The phase III study titled, “An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients with Schizophrenia (EMERGENT-5)” will evaluate the investigational therapy KarXT for the treatment of schizophrenia, a serious and potentially disabling condition affecting approximately 20 million people worldwide.1

“Current antipsychotic drugs fall short for too many individuals with schizophrenia, leaving them with either debilitating symptoms or serious side effects like sedation, weight gain and involuntary movements,” said Dr. Reid Robison, Novamind’s Chief Medical Officer and Principal Investigator at CCR. “We need more innovation in this field and I’m hopeful to see compounds like KarXT that have new ways of acting on the brain and the potential for improved efficacy and side effect profiles.”

Novamind’s CCR is specialized in hosting clinical trials for psychedelic medicines and other innovative therapies. CCR’s research sites are co-located with Novamind’s Cedar Psychiatry clinics allowing for large client population recruitment and providing clients access to innovative research stage treatments. In 2021, Cedar Psychiatry anticipates 65,000 clinic visits, a 225 per cent year-over-year increase. CCR is currently contracted for eight clinical trials, leveraging its expertise in study design, patient recruitment and patient management. CCR has an established track record working alongside leading drug development companies, non-profits and academic institutions including Merck & Co., Bionomics, the Ketamine Research Foundation and the University of Texas, Austin.

“While Novamind remains focused on psychedelic medicine, we also provide treatments and conduct innovative research across the entire mental health spectrum,” said Yaron Conforti, CEO and Director. “We are dedicated to serving our clients’ diverse needs and providing access to the most innovative treatments, as there is no one single solution to solve society’s mental health crisis.”

To learn more about the phase III EMERGENT-5 trial with CCR, please visit this link.

About Novamind
Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of Cedar Psychiatry clinics and operates Cedar Clinical Research, a contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. Both Cedar Psychiatry and Cedar Clinical Research are wholly owned subsidiaries of Novamind. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visit novamind.ca.

Contact Information
Novamind
Yaron Conforti, CEO and Director
Telephone: +1 (647) 953 9512

Samantha DeLenardo, VP, Communications
Email: media@novamind.ca

Bill Mitoulas, Investor Relations
Email: bill@novamind.ca

Forward-Looking Statements
This news release contains forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations including the risks detailed from time to time in the Company’s public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.

1: GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. (2018). Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. The Lancet, 392(10159), 1789-1858. https://doi.org/10.1016/S0140-6736(18)32279-7

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Red Light Holland Expands iMicrodose Branded Product Offerings and Launches the Sale of All-in-One Mushroom Fruiting Extracts; Capsules and Tinctures

Red Light Holland Expands iMicrodose Branded Product Offerings and Launches the Sale of All-in-One Mushroom Fruiting Extracts; Capsules and Tinctures

Toronto, Ontario–(Newsfile Corp. – September 13, 2021) – Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTC Pink: TRUFF) (“Red Light Holland” or the “Company“), an Ontario-based corporation engaged in the production, growth, and sale of a premium brand of magic truffles, is pleased to announce they have expanded their iMicrodose product offerings as their iMicrodose All-In-One Mushroom Fruiting Extracts (“iMicrodose All-In-One Fruiting Extracts“) powered by Red Light Holland are now available for sale (Business to Business) through Red Light Holland’s wholly owned subsidiary SR Wholesale (“SR Wholesale”) across Europe. As well, iMicrodose All-In-One Fruiting Extracts powered by Red Light Holland, which are available in both (i) Capsules and (ii) Tinctures, are expected to be for sale (Business to Consumer) on the company’s advanced e-commerce platform at www.iMicrodose.nl by mid October 2021.

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Pictured: iMicrodose All-In-One Mushroom Fruiting Extracts Products powered by Red Light Holland

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“Expanding our iMicrodose product offerings powered by Red Light Holland has always been a big part of our long term strategy to increase revenues and increase our brand exposure,” said Todd Shapiro, Chief Executive Officer and Director of the Company. “SR Wholesale has established a distribution network of over 300 companies that can sell products across Europe, including working with sub-distributors which provide products to over 1,000 shops in countries like the Netherlands, Germany, Spain, Czech, Greece, UK, France, and Portugal. Having these All-In-One Mushroom Fruiting Extracts in our product line up is very exciting as they allow us to reach out to SR Wholesale’s entire network, which fits our ultimate growth strategy in both building a responsible use recreational brand while continuing to develop new Red Light Holland products that can one day be sold across the world, if and when regulations permit. And I love the eye catching labels!”

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Pictured: iMicrodose All-In-One Fruiting Extract powered by Red Light Holland

To view an enhanced version of this graphic, please visit:
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“Our Market Research has shown us that Mushroom products are in high demand and are considered by many store owners, big or small, to be a high growth sector,” said Hans Derix, Red Light Holland’s President. “Our team in the Netherlands are very proud to be so aggressive in this sector and we look forward to launching the iMicrodose All-In-One Mushroom products via SR Wholesale and soon online at www.iMicrodose.nl. The Farm in Horst, The Netherlands and SR Wholesale continue to run very smoothly which have allowed us to focus on increasing our products for sale. We are thrilled to continue building the iMicrodose powered by Red Light Holland Brand and look forward to customer feedback.”

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Pictured: iMicrodose All-In-One Fruiting Extract (Capsules) powered by Red Light Holland

To view an enhanced version of this graphic, please visit:
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About Red Light Holland Corp.

The Company is an Ontario-based corporation engaged in the production, growth and sale (through existing Smart Shops operators and an advanced e-commerce platform) of a premium brand of magic truffles to the legal market within the Netherlands.

For additional information on the Company:

Todd Shapiro
Chief Executive Officer & Director
Tel: 647-204-7129
Email: todd@redlighttruffles.com
Website: https://redlighttruffles.com/

Forward-Looking Statements

This press release contains certain “forward-looking information” within the meaning of applicable Canadian securities legislation. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company’s beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company’s control. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or their respective subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained in this news release. Examples of such information include statements with respect to: the anticipated sales abilities, network, connections and the reach of SR Wholesale; the commencement and projected sales’ dates regarding the Company’s All-In-One Mushroom Products from SR Wholesale and/or the Company’s website www.iMicrodose.nl; statements about the future of the Company’s iMicrodose All-In-One Mushroom Products, including with respect to the future sales; and expectations for other economic, business, and/or competitive factors.

Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, expectations regarding future growth and expansion of the operations of the business; regulatory and licensing risks; changes in general economic, business and political conditions, including changes in the financial and stock markets; risks related to infectious diseases, including the impacts of the COVID-19 pandemic; legal and regulatory risks inherent in the psychedelics industry, including the global regulatory landscape and enforcement related to psychedelics; political risks and risks relating to regulatory change; risks relating to anti-money laundering laws; compliance with extensive government regulation and the interpretation of various laws regulations and policies; public opinion and perception of the psychedelics industry; and such other risks contained in the public filings of the Company filed with Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com, including the Company’s annual information form for the year ended March 31, 2020.

Although the Company believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements. The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws

The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws.